US Drug Recall Register

FDA Drug Recalls

1,709 recalls · Class III, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class III · Low risk Terminated

BuPROPion Hydrochloride Extended-release Tablets

Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-317-60 D-0671-2017
Class III · Low risk Terminated

BuPROPion Hydrochloride Extended-release Tablets

Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-316-60 D-0670-2017
Class III · Low risk Terminated

BuPROPion Hydrochloride Extended-release Tablets

Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-315-60 D-0669-2017
Class III · Low risk Terminated

Haloperidol Decanoate Injection

Reason Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.

Fresenius Kabi USA, LLC NDC 63323-469-01 D-0818-2016
Class III · Low risk Terminated

Lisinopril Tablets USP

Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Lupin Pharmaceuticals Inc. NDC 68180-517-03 D-1503-2016
Class III · Low risk Terminated

Lisinopril Tablets USP

Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Lupin Pharmaceuticals Inc. NDC 68180-516-02 D-1502-2016
Class III · Low risk Terminated

Lisinopril & Hydrochlorothiazide Tables

Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Lupin Pharmaceuticals Inc. NDC 68180-519-01 D-1052-2016
Class III · Low risk Terminated

¿Topicort

Reason Subpotent Drug

Taro Pharmaceuticals U.S.A., Inc. D-0950-2016
Class III · Low risk Terminated

Fenofibrate Capsules

Reason Labeling: Incorrect or Missing Lot and/or Exp Date

Amerisource Health Services NDC 68084-835-32 D-0823-2016
Class III · Low risk Terminated

Fenofibrate Capsules

Reason Labeling: Incorrect or Missing Lot and/or Exp Date

Amerisource Health Services NDC 68084-835-32 D-0822-2016
Class III · Low risk Terminated

Intermezzo

Reason Failed Dissolution Specifications

Purdue Pharma L.P. D-0810-2016
Class III · Low risk Terminated

Venlafaxine 75 mg Tablet

Reason Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.

Bryant Ranch Prepack Inc. NDC 63629-3324-6 D-0837-2016
Class III · Low risk Terminated

Escitalopram Tablets USP 20 mg

Reason Labeling: Incorrect or Missing Lot and/or Expiration Date

Lupin Limited NDC 68180-136-01 D-1516-201
Class III · Low risk Terminated

Zemplar

Reason Failed Content Uniformity Specifications

AbbVie Inc. NDC 0074-4317-30 D-0833-2016
Class III · Low risk Terminated

Simvastatin Tablets

Reason Subpotent Drug

Biocon Inc NDC 24658-0300-90 D-0817-2016
Class III · Low risk Ongoing

Magnesium Sulfate Inj.

Reason Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.

Hospira Inc. NDC 0409-2168-02 D-0854-2016
Class III · Low risk Terminated

Fenofibrate Capsules

Reason Labeling: Incorrect or Missing Lot and/or Exp. Date

Impax Laboratories, Inc. NDC 0115-0533-02 D-0821-2016
Class III · Low risk Terminated

Fenofibrate Capsules

Reason Labeling: Incorrect or Missing Lot and/or Exp. Date

Impax Laboratories, Inc. NDC 0115-0522-02 D-0820-2016
Class III · Low risk Terminated

Ciprofloxacin Ophthalmic Solution

Reason Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).

Actavis Pharma Inc D-1060-2016
Class III · Low risk Ongoing

Quelicin

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.

Hospira Inc. NDC 0409-6629-02 D-0836-2016
Class III · Low risk Terminated

Ceftriaxone Sodium

Reason CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.

Lupin Pharmaceuticals Inc. D-0955-2016
Class III · Low risk Terminated

Ceftriaxone for Injection USP

Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Lupin Pharmaceuticals Inc. NDC 68180-644-01 D-0954-2016
Class III · Low risk Terminated

Ceftriaxone for Injection USP

Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Lupin Pharmaceuticals Inc. NDC 68180-633-01 D-0953-2016
Class III · Low risk Terminated

Ceftriaxone for Injection USP

Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Lupin Pharmaceuticals Inc. NDC 68180-622-01 D-0952-2016
Class III · Low risk Terminated

Ceftriaxone for Injection USP

Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Lupin Pharmaceuticals Inc. NDC 68180-611-01 D-0951-2016